Only fed study [Design Issues]

posted by roody – 2005-10-04 17:10 (5394 d 19:25 ago) – Posting: # 36
Views: 16,594

With reference to ANDA submission for US FDA, If the prescribing information says that the drug has to be taken under fed condition then whether it is necessary to conduct both fasted and fed studies? Can we only submit the fed study for immediate release formulation?

Complete thread:

 Admin contact
20,819 posts in 4,356 threads, 1,447 registered users;
online 23 (1 registered, 22 guests [including 14 identified bots]).
Forum time: 12:35 UTC (Europe/Vienna)

Statistics are no substitute for judgment.    Henry Clay

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz